Replacement heart valve

ABSTRACT

A replacement heart valve assembly has a stent frame and a replacement valve. The replacement valve has a plurality of leaflets and a valve frame. The leaflets are attached to the valve frame. Further, the assembly has a plurality of suspension struts attached to the stent frame and the valve frame. The valve frame is suspended within the stent frame via the suspension struts. In some embodiments, the assembly further has a sealing member attached to the stent frame to prevent leakage around the replacement heart valve assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of U.S. application Ser. No.13/920,847, filed Jun. 18, 2013, which claims the benefit of andpriority to U.S. Provisional Application No. 61/661,586, filed Jun. 19,2012, the entire contents of which are herein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable.

BACKGROUND OF THE INVENTION

It is known that heart valve insufficiency, stenosis, and defects canresult in mortality of a patient. Heretofore, a variety of methods anddevices have been designed to allay such conditions. One particularoption is to use a replacement heart valve. Moreover, various types ofreplacement heart valves are implanted via minimally invasivetechniques, for example transcatheter implantation.

One particular type of congenital defect is a bicuspid aortic valve.Bicuspid aortic valves are present in approximately 1%-2% of the generalpopulation and can lead to additional heart complications. C. Ward,Clinical Significance of the Bicuspid Aortic Valve, 83 Heart 81, 82(2000). For example, approximately 50% of adults affected by severeaortic stenosis have a bicuspid aortic valve. Id.

In addition, while existing technologies offer some solutions forpatients suffering from stenosis and/or valve insufficiency, theseexisting technologies suffer from a number of problems in bicuspidaortic valve applications. In particular, existing transcatheter valvereplacement technologies have difficulty with bicuspid valves since thegeometry of the existing valve tends to force the replacement valve outof round. This leads to increased stress within the replacement valve,reduced coaptation, and, consequently, reduced valve life. Therefore,there is a need for effective treatment options for individuals havingcongenital bicuspid valves or valves that have begun to function likebicuspid valves due to plaque build-up on the valve.

The art referred to and/or described above is not intended to constitutean admission that any patent, publication or other information referredto herein is “prior art” with respect to this invention. In addition,this section should not be construed to mean that a search has been madeor that no other pertinent information as defined in 37 C.F.R..sctn.1.56(a) exists.

All US patents and applications and all other published documentsmentioned anywhere in this application are incorporated herein byreference in their entirety.

Without limiting the scope of the invention a brief summary of some ofthe claimed embodiments of the invention is set forth below. Additionaldetails of the summarized embodiments of the invention and/or additionalembodiments of the invention may be found in the Detailed Description ofthe Invention below.

BRIEF SUMMARY OF THE INVENTION

In some embodiments, a replacement heart valve assembly comprises astent frame and a replacement heart valve. In some embodiments, thereplacement valve has a plurality of leaflets and a valve frame. Thevalve leaflets are attached to the valve frame. In some embodiments, theassembly further comprises a plurality of suspension struts attached tothe stent frame and the valve frame. In some embodiments, the valveframe is suspended within the stent frame via the suspension struts. Insome embodiments, the assembly further comprises a sealing member andthe sealing member is attached to the stent frame. In some embodiments,the sealing member is configured to prevent perivalvular leaks.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1A shows a top view of a replacement heart valve assembly 10 withina native heart valve 2.

FIG. 1B shows a top view of the stent frame 12 of FIG. 1A in anunrestricted configuration 16.

FIG. 1C shows a top view of a native heart valve 2.

FIG. 2 shows a top view of an embodiment of a replacement heart valveassembly 10 within a native heart valve 2.

FIG. 3 shows a side view of an embodiment of a replacement heart valveassembly 10 within a native heart valve 2.

DETAILED DESCRIPTION OF THE INVENTION

While this invention may be embodied in many different forms, there aredescribed in detail herein specific embodiments. This description is anexemplification of the principles of the invention and is not intendedto limit it to the particular embodiments illustrated.

For the purposes of this disclosure, like reference numerals in thefigures shall refer to like features unless otherwise indicated.

With regard to FIG. 1A, in some embodiments, a replacement heart valveassembly 10 comprises a stent frame 12 and a replacement valve 14. Thereplacement valve 14 is attached to the stent frame 12 and, in someembodiments, has a plurality of leaflets 20. As further shown in FIG.1A, the replacement heart valve assembly 10 is inserted into a nativeheart valve 2. As shown in FIG. 1A, the replacement heart valve assembly10 is in a deployed configuration 17.

Turning to FIG. 1B, the stent frame 12 of FIG. 1A is shown therein in anunrestricted configuration 16. In some embodiments, in the unrestrictedconfiguration 16, the stent frame 12 has an oval or elliptical shape. Asused herein, the phrase “unrestricted configuration” refers to aconfiguration in which the stent frame 12 and/or replacement heart valveassembly 10 has been expanded but does not have any outside force actingon the stent frame 12 and/or replacement heart valve assembly 10. Insome embodiments, when the stent frame 12 is in the unrestrictedconfiguration, the leaflets 20 are not in alignment.

In some embodiments, the stent frame 12 is stiffer in one direction thananother. For example, in some embodiments, the stent frame 12 is stifferin a first direction 30 than a second direction 32. Further, in someembodiments, the stent frame 12 has fewer struts along a portion thereofthat is desirably less stiff and more struts along a portion thereofthat is desirably stiffer.

When used with a stenosed or bicuspid aortic valve 2, as shown in FIG.1C, the stent frame 12 of FIG. 1B is placed within the aortic valve suchthat, upon deployment, the stent frame 12 assumes a circularconfiguration, for example as shown in FIG. 1A. This, in turn, allowsthe replacement valve 14 to coapt, improving valve performance andlongevity. Moreover, the stent frame 12 of FIG. 1B can, for example, beinserted into the native heart valve 2 shown in FIG. 1C so that thefirst direction 30 of FIG. 1B aligns with the first direction 30 shownin FIG. 1C. In this way, where the bicuspid aortic valve of FIG. 1Casserts a greater force in the first direction 30 than the seconddirection 32, the stent frame 12 (FIG. 1B) counteracts the appliedforces to yield a circular stent frame 12, when disposed within thenative aortic valve 2, shown in FIG. 1A.

As further shown in FIGS. 1A and 1B, in some embodiments, the stentframe 12 has a non-uniform thickness. In this way, the stent frame 12 isbiased to be stiffer in one direction than the other. Such a structurecounteracts the force applied to the stent frame 12 by a bicuspid and/orstenosed heart valve. The non-uniform thickness aids the stent frame 12in resisting the non-uniform force applied to the stent frame 12 by thebicuspid aortic valve. Upon implantation, the resulting replacementheart valve assembly 10 takes on a circular configuration. Consequently,the leaflets 20 come together, upon closing of the replacement valve 14,to provide improved coaptation. With further regard to FIG. 1B, in someembodiments, the stent frame 12 is thickest at the intersection of theminor axis 36 and thinnest at the intersection of the major axis 34. Insome embodiments, the stent frame 12 is stiffer in the direction of themajor axis 34 than the direction of the minor axis 36.

In some embodiments, the stent frame 12 is circular in both the deployedconfiguration 17 and the unrestricted configuration 16. In particular,in such an embodiment, the stent frame 12 comprises a non-uniformstructure to counteract a greater force applied to the stent frame 12 inthe first direction 30 than in the second direction 32.

In addition to the foregoing, in some embodiments, the stent frame 12 isstiffer in one direction than another by way of the strut configuration,strut width, or strut length. Other suitable structures can be employedto bias the stent frame 12 to counteract the forces applied by abicuspid aortic valve and/or stenosed aortic valve. For example, thetemper of the stent frame 12 can be varied by region.

Upon introduction, in some embodiments, the stent frame 12 exerts agreater force on the diseased valve along the major axis 34, directedparallel to the first direction 30 (FIG. 1C), than it does along theminor axis 36, directed parallel to the second direction 32. Further, insome embodiments, the major axis 34 is oriented towards the greatestamount of stiff plaque.

Turning to FIG. 2, in some embodiments, the stent frame 12 has anelliptical shape that is retained upon deployment into the native aorticvalve 2. More particularly, in some embodiments, the stent frame 12 isoriented within the native aortic valve 2, for example a bicuspid aorticvalve, such that the elliptical shape of the stent frame 12 is alignedwith the oblong shape of the native aortic valve 2. Stated differently,in some embodiments, the stent frame 12 has a major axis 34 that isaligned with the second direction 32.

In some embodiments, for example as further shown in FIG. 2, theleaflets 20 are shaped to coapt when the stent frame 12 has anelliptical shape. Moreover, in some embodiments, two of the leaflets 20a and 20 b are the same, while leaflet 20 c has a shape different fromthat of leaflets 20 a and 20 b.

With regard to FIG. 3, in some embodiments, a replacement heart valveassembly 10 comprises a stent frame 12, a replacement valve 14, and aplurality of suspension struts 18 extending from the stent frame 12. Thestent frame 12 has a proximal end 26 and an opposed distal end 28. Insome embodiments, the replacement valve 14 comprises a plurality ofleaflets 20 and a valve frame 22. In some embodiments, the leaflets 20are attached to the valve frame 22 for example by sutures. The leaflets20 can also be attached to the valve frame 22 in other ways, for exampleas disclosed in U.S. Publication No. 2009/0041978; U.S. Publication No.2009/0117334; and U.S. Publication No. 2007/0067021, each of which isherein incorporated by reference in its entirety.

In some embodiments, the suspension struts 18 extend from the stentframe 12 to the valve frame 22; in this way, the valve frame 22 issuspended within the stent frame 12 via suspension struts 18. In someembodiments, the suspension struts 18 extend radially inwardly from thestent frame 12 and attach to the valve frame 22, which is disposedwithin the stent frame 12.

In some embodiments, in the deployed configuration, the stent frame 12is elliptical and the valve frame 22 is circular. In this way, the stentframe 12 closely matches the shape of a native bicuspid aortic valve,while the valve frame 22 takes on a circular configuration to promotecoaptation of the leaflets 20. Further, in some embodiments, theleaflets 20 are all the same shape.

In some embodiments, the replacement heart valve assembly 10 furthercomprises a sealing member 24. In some embodiments, the sealing member24 is disposed exteriorly to the stent frame 12 to prevent leakage ofblood around the stent frame 12.

In some embodiments, suspension of the replacement valve 14 within thestent frame 12 permits the replacement valve 14 to obtain a circularshape even though the stent frame 12 is somewhat elongated orelliptical. In particular, in some embodiments, the suspension struts 18can deform upon deployment of the stent frame 12 and replacement valve14 to allow the stent frame 12 to take on an elliptical configuration,and match the native valve geometry, while the replacement valve 14takes on a circular configuration, to achieve the desired leaflet 20geometry. In this way, in some embodiments, the suspension struts 18 areflexible enough to accommodate an elliptical stent frame 12 and circularreplacement valve 14.

In some embodiments, the suspension struts 18 extend from the distal end28 of the stent frame 12. Additionally, in some embodiments, the sealingmember 24 is attached to the distal end 28 of the stent frame 12. Insome embodiments, at least a portion of the sealing member 24 isdisposed exteriorly to the stent frame 12.

In some embodiments, the replacement heart valve assembly 10 isself-expanding. In some embodiments, however, the replacement heartvalve assembly 10 is balloon expandable. Further, in some embodiments,the heart valve assembly 10 is partially self-expanding and partiallyballoon expandable. Further still, in some embodiments, one or more ofthe components of the replacement heart valve assembly 10 isself-expanding while other of the components is balloon expandable.

In some embodiments, the stent frame 12 is a slotted-tube style stent.Alternatively, in some embodiments, the stent frame 12 is formed from awoven or braided wire. In some embodiments, for example where the stentframe 12 is formed from a braided wire, it can be heat-set into anelliptical shape.

The above disclosure is intended to be illustrative and not exhaustive.This description will suggest many variations and alternatives to one ofordinary skill in this art. The various elements shown in the individualfigures and described above may be combined or modified for combinationas desired. All these alternatives and variations are intended to beincluded within the scope of the claims where the term “comprising”means “including, but not limited to”.

Further, the particular features presented in the dependent claims canbe combined with each other in other manners within the scope of theinvention such that the invention should be recognized as alsospecifically directed to other embodiments having any other possiblecombination of the features of the dependent claims. For instance, forpurposes of claim publication, any dependent claim which follows shouldbe taken as alternatively written in a multiple dependent form from allprior claims which possess all antecedents referenced in such dependentclaim if such multiple dependent format is an accepted format within thejurisdiction (e.g. each claim depending directly from claim 1 should bealternatively taken as depending from all previous claims). Injurisdictions where multiple dependent claim formats are restricted, thefollowing dependent claims should each be also taken as alternativelywritten in each singly dependent claim format which creates a dependencyfrom a prior antecedent-possessing claim other than the specific claimlisted in such dependent claim below.

This completes the description of the invention. Those skilled in theart may recognize other equivalents to the specific embodiment describedherein which equivalents are intended to be encompassed by the claimsattached hereto.

What is claimed is:
 1. A replacement valve assembly comprising: a firsttubular frame having a first diameter, a first end, a second end, alumen extending from the first end to the second end, and a longitudinalaxis; a second tubular frame having a second diameter, a first end, asecond end, a lumen extending from the first end of the second tubularframe to the second end of the second tubular frame, and a longitudinalaxis coinciding with the longitudinal axis of the first tubular frame,wherein the first diameter is greater than the second diameter; areplacement valve comprising a plurality of leaflets disposed within andattached to the second tubular frame; a plurality of struts suspendingthe second tubular frame at least partially within the first tubularframe, wherein the plurality of struts directly connect the first end ofthe first tubular frame to the first end of the second tubular frame;and a sealing member disposed on the first frame, wherein the sealingmember is configured to prevent leakage of blood around the first frame.2. The replacement valve assembly of claim 1, wherein the first tubularframe has a non-uniform thickness.
 3. The replacement valve assembly ofclaim 1 having a transverse cross-section, wherein the first tubularframe is non-circular and the second tubular frame is circular.
 4. Thereplacement valve assembly of claim 1, wherein the replacement valveassembly is self-expanding.
 5. The replacement valve assembly of claim1, wherein the replacement valve has 3 leaflets.
 6. The replacementvalve assembly of claim 1, wherein the second end of the first tubularframe is an outflow end of the replacement valve assembly.
 7. Areplacement valve assembly, comprising: a first frame having a firstend, a second end, a lumen extending from the first end of the firstframe to the second end of the first frame, and a longitudinal axis; asecond frame having a first end and a second end, wherein the secondframe is disposed within the lumen of the first frame; a plurality ofstruts suspending the second frame at least partially within the lumenof the first frame, wherein the first end of the first frame is directlyconnected to the first end of the second frame by the plurality ofstruts; a replacement valve disposed within and connected to the secondframe, wherein the replacement valve has a plurality of leaflets; and asealing member disposed on the first frame, wherein the sealing memberis configured to prevent leakage of blood around the first frame.
 8. Thereplacement valve assembly of claim 7, wherein the first frame adjuststo a non-circular shape.
 9. The replacement valve assembly of claim 8,wherein the non-circular shape is elliptical.
 10. The replacement valveassembly of claim 7, wherein the replacement valve assembly isself-expanding.
 11. The replacement valve assembly of claim 7, whereinthe sealing member is attached to an inflow end of the first frame. 12.The replacement valve assembly of claim 7, wherein the plurality ofleaflets are connected to the second frame.
 13. The replacement valveassembly of claim 7, wherein the second end of the first frame is anoutflow end of the replacement valve assembly.